Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
- Conditions
- Esophagitis
- Interventions
- Drug: Full dose Pantoprazole plus matching placeboDrug: Half Dose Pantoprazole plus matching placebo
- Registration Number
- NCT04821310
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
- Detailed Description
Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment:
- Capable of giving signed informed consent/assent
- Willingness and ability of the participant or parent/legal guardian to complete the eDiary
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary.
- Male and female participants aged 1 to 17 years.
- Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center for Disease Control standard age and weight chart, for the participant's age.
- To be considered a female of non childbearing potential, the participant must meet at least 1 of the following criteria :
- Premenarchal: The investigator (or other appropriate staff) must discuss the participant's premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered "female participants of non childbearing potential" and must comply with the protocol requirements applicable to women of childbearing potential.
- Previous administration of an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation
- History or presence of upper gastrointestinal anatomic or motor disorders
- Family history of malignant hyperthermia
- Known hypersensitivity to any Proton Pump Inhibitor, including pantoprazole or to any substituted benzimidazole or to any of the excipients.
- Any disorder requiring chronic (daily) use of warfarin, heparin, other anticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potent inhibitors or inducers of CYP2C19 (eg, phenytoin, sulfamethoxazole, valproic acid, carbamazepine, and griseofulvin).
- Serum creatine kinase levels >3 x upper limit of normal.
- Known history of human immunodeficiency virus or clinical manifestations of acquired immune deficiency syndrome.
- Active malignancy of any type, or history of a malignancy. Participants with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable.
- Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before the Screening visit.
- Alanine aminotransferase or blood urea nitrogen >2.0 upper limit of normal or estimated creatinine >1.5 X upper limit of normal for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before the Baseline Visit (Day 1).
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Has, in the Investigator's opinion, a serious chronic condition (eg, diabetes, epilepsy), which is either not stable or not well controlled and may interfere with the conduct of the study.
- Has any condition possibly affecting drug absorption (eg, gastrectomy).
Prior or Concomitant Therapy:
- Frequent, repeated use of oral or parenteral glucocorticoids (eg, prednisone, prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used.
- Pregnant female participants; breastfeeding female participants.
- Is unwilling or unable to comply with the Lifestyle Considerations section
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Full Dose Pantoprazole and matching placebo Full dose Pantoprazole plus matching placebo Full Healing Dose of pantoprazole Arm 2 Half Dose Pantoprazole and matching placebo Half Dose Pantoprazole plus matching placebo Half Healing Dose of pantoprazole
- Primary Outcome Measures
Name Time Method Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures Week 24 Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.
- Secondary Outcome Measures
Name Time Method Number of Participants With Change From Baseline in Physical Examinations and Vital Signs Baseline up to 36 weeks Safety and tolerability will be assessed by physical examinations, blood pressure, and pulse rate.
Incidence of Adverse Events (AEs) Baseline up to 36 weeks Number of Participants With Change From Baseline in Laboratory Tests Results Baseline up to 36 weeks Safety and tolerability will be assessed by clinical laboratory measurements
Trial Locations
- Locations (51)
JSC Georgian Clinics
🇬🇪Tbilisi, Georgia
Medical college and Hospital
🇮🇳Kolkata, WEST Bengal, India
CLINIQ s.r.o.
🇸🇰Bratislava, Slovakia
Childrens Hospital of Orange County
🇺🇸Orange, California, United States
Baptist/Wolfson's Children's Hospital
🇺🇸Jacksonville, Florida, United States
Nemours Children's Specialty Care
🇺🇸Jacksonville, Florida, United States
Children's Healthcare of Atlanta-Egleston
🇺🇸Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
🇺🇸Atlanta, Georgia, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Unity Point Health Pediatric Gastroenterology
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University of Rochester Medical Center Clinical Research Center
🇺🇸Rochester, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Health / Children's Medical Center
🇺🇸Dallas, Texas, United States
Cabell Huntington Hospital Endoscopy Suite (Endoscopy Only)
🇺🇸Huntington, West Virginia, United States
University Physicians and Surgeons, Inc dba Marshall Health
🇺🇸Huntington, West Virginia, United States
UW Health E Terrace Dr Medical Center
🇺🇸Madison, Wisconsin, United States
University Hospital and UW Health Clinics
🇺🇸Madison, Wisconsin, United States
UW Health 2275 Deming Way Clinic
🇺🇸Middleton, Wisconsin, United States
UZ Brussel
🇧🇪Brussel, Belgium
University clinical center of the Republic of Srpska
🇧🇦Banja Luka, Bosnia and Herzegovina
New Hospitals
🇬🇪Tbilisi, Georgia
LTD Imedi Clinic
🇬🇪Tbilisi, Georgia
Pediatric Clinic after G. Zhvania
🇬🇪Tbilisi, Georgia
Georgian-American Family Medicine Clinic
🇬🇪Tbilisi, Georgia
Evex clinic after I. Tsitsishvili
🇬🇪Tbilisi, Georgia
Szegedi Tudományegyetem
🇭🇺Szeged, Csongrád, Hungary
Heim Pal Pediatric Hospital
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Gujarat Hospital - Gastro & Vascular Centre
🇮🇳Surat, Gujarat, India
Sanjeevani Children's Hospital
🇮🇳Aurangabad, Maharashtra, India
SR Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, Rajasthan, India
Yashoda Hospitals
🇮🇳Secunderabad, Telangana, India
Hospital HIMA San Pablo Caguas
🇵🇷Caguas, Puerto Rico
Chiara Biaggi de Casenave, MD
🇵🇷Guaynabo, Puerto Rico
Puerto Rico Consortium for Clinical Investigation
🇵🇷San Juan, Puerto Rico
University Children's Hospital
🇷🇸Belgrade, Serbia
University Clinical Center of Kragujevac
🇷🇸Kragujevac, Serbia
Detska fakultna nemocnica s poliklinikou Banska Bystrica
🇸🇰Banska Bystrica, Slovakia
Narodny ustav detskych chorob
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica Martin, Klinika deti a dorastu
🇸🇰Martin, Slovakia
KM Management, spol. s r.o.,
🇸🇰Nitra, Slovakia
SBU Izmir Tepecik EAH
🇹🇷Izmir, Turkey
T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
🇹🇷Izmir, Turkey
Queen Mary's Hospital for Children, Epsom and St Helier University Hospitals NHS Trust
🇬🇧Carshalton, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Evelina London Children's Hospital
🇬🇧London, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
🇬🇧London, United Kingdom